Dexamethasone

Generic Name: Dexamethasone

Brand Names: Baycadron, Ciprodex, Decadron, Dexamethasone Intensol, Dextenza, Dioptrol, Hexadrol, Hidex 6-day Taper, Maxidex, Maxitrol, Neofordex, Ozurdex, Taperdex 12 Day Taper, Taperdex 6 Day Taper, Taperdex 7-day Taper, Tobradex, Zcort 7 Day Taper

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₉FO_₅

CAS Number: 50-02-2

Unique Ingredient Identifier: 7S5I7G3JQL

Background: Dexamethasone, or MK-125, is a corticosteroid fluorinated at position 9 used to treat endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, gastrointestinal, respiratory, hematologic, neoplastic, edematous, and other conditions. Developed in 1957, it is structurally similar to other corticosteroids like hydrocortisone and prednisolone.

Dexamethasone was granted FDA approval on 30 October 1958. In a press release for the Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial on 16 June 2020, dexamethasone was recommended for use in COVID-19 patients with severe respiratory symptoms. Dexamethasone reduced deaths by approximately one third in patients requiring ventilation and by one fifth in those requiring oxygen.

Indication: Dexamethasone and ciprofloxacin otic suspension is indicated for bacterial infections with inflammation in acute otitis media and acute otitis externa. Intramuscular and intravenous injections are indicated for a number of endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, gastrointestinal, respiratory, hematologic, neoplastic, edematous, and other conditions. Oral tablets are indicated for the treatment of multiple myeloma. An intravitreal implant is indicated for some forms of macular edema and non-infectious posterior uveitis affecting the posterior of the eye. Various ophthalmic formulations are indicated for inflammatory conditions of the eye.

Associated Conditions: Acute Gouty Arthritis, Acute Leukemia, Acute Otitis Externa, Acute Otitis Media (AOM), Adrenocortical Hyperfunction, Adrenocortical Insufficiency, Allergic Conjunctivitis (AC), Alopecia Areata (AA), Ankylosing Spondylitis (AS), Aspiration Pneumonitis, Asthma, Atopic Dermatitis, Berylliosis, Bullous dermatitis herpetiformis, Bursitis, Chorioretinitis, Choroiditis, Congenital Adrenal Hyperplasia (CAH), Congenital Hypoplastic Anemia, Conjunctivitis, Contact Dermatitis, Cushing's Syndrome, Dermatitis, Diabetic Macular Edema (DME), Discoid Lupus Erythematosus (DLE), Drug hypersensitivity reaction, Edema of the cerebrum, Epicondylitis, Episcleritis, Erythroblastopenia, Eye Infections, Eye allergy, Glaucoma, Hypercalcemia, Immune Thrombocytopenia (ITP), Infection, Inflammation, Inflammation of the External Auditory Canal, Intraocular Inflammation, Iridocyclitis, Iritis, Keloids Scars, Keratitis, Lichen Planus (LP), Lichen simplex chronicus, Loeffler's syndrome, Lymphoma, Macular Edema, Meningitis caused by Mycobacterium Tuberculosis, Middle ear inflammation, Mucosal Inflammation of the eye, Multiple Myeloma (MM), Muscle Inflammation caused by Cataract Surgery of the eye, Mycosis Fungoides (MF), Necrobiosis lipoidica diabeticorum, Non-infectious Posterior Uveitis, Ocular Infections, Irritations and Inflammations, Ocular Inflammation, Ocular Inflammation and Pain, Ocular Irritation, Ocular Itching, Ophthalmia, Sympathetic, Optic Neuritis, Otitis Externa, Pemphigus, Perennial Allergic Rhinitis (PAR), Phlyctenular keratoconjunctivitis, Postoperative Infections of the eyes caused by susceptible bacteria, Posttraumatic Osteoarthritis, Regional Enteritis, Rheumatoid Arthritis, Rheumatoid Arthritis, Juvenile, Rosacea, Sarcoidosis, Scleritis, Seasonal Allergic Rhinitis, Secondary thrombocytopenia, Serum Sickness, Severe Seborrheic Dermatitis, Stevens-Johnson Syndrome, Synovitis, Systemic Lupus Erythematosus, Tenosynovitis, Trichinosis, Tuberculosis (TB), Ulcerative Colitis, Uveitis, Vernal Keratoconjunctivitis, Acquired immune hemolytic anemia, Acute rheumatic carditis, Anterior eye segment inflammation, Corticosteroid-responsive dermatoses, Ear infection-not otherwise specified caused by susceptible bacteria, Exfoliative erythroderma, Granuloma annulare lesions, Non-suppurative Thyroiditis, Ocular bacterial infections, Severe Psoriasis, Steroid-responsive inflammation of the eye, Swelling of the eyes, Varicella-zoster virus acute retinal necrosis, Watery itchy eyes

Associated Therapies: -

Clinical Trials

Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2015 (ALL-MB 2015)

Not Applicable

Recruiting

Conditions: Childhood Acute Lymphoblastic Leukemia

Interventions: Drug: Dexamethasone intermittent
Drug: Dexamethasone continuous
Drug: Second phase of induction
Drug: Standard induction therapy
Drug: Standard consolidation therapy
Drug: Dexamethasone
Drug: Idarubicin
Drug: Daunorubicin
Drug: Bortezomib
Drug: Methylprednisolone

First Posted Date: 2018-01-04

Last Posted Date: 2020-02-05

Lead Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Target Recruit Count: 4000

Registration Number: NCT03390387

Locations: 🇷🇺
Morozov Children's Municipal Clinical Hospital, Moscow, Russian Federation
🇦🇲
prof. R.O.Eolyan Hematology Center, Ereván, Armenia
🇷🇺
Transbaikal Regional Oncology Dispensary, Chita, Russian Federation

and more 45 locations

Transforaminal Versus Lateralized Interlaminar Cervical Epidurals

Phase 2

Completed

Conditions: Cervicogenic Upper Extremity Radiculopathy

Interventions: Drug: dexamethasone

First Posted Date: 2018-01-03

Last Posted Date: 2023-11-03

Lead Sponsor: Duke University

Target Recruit Count: 74

Registration Number: NCT03389620

Locations: 🇺🇸
Duke Radiology and Orthopaedic Clinic, Durham, North Carolina, United States

Intrathecal Atropine to Prevent Postoperative Nausea and Vomiting

Not Applicable

Completed

Conditions: Postoperative Nausea

Interventions: Drug: Intrathecal atropine
Drug: dexamethasone

First Posted Date: 2018-01-02

Last Posted Date: 2018-06-06

Lead Sponsor: Assiut University

Target Recruit Count: 120

Registration Number: NCT03387956

Locations: 🇪🇬
Emad Zarief Kamel Said, Assiut, Egypt

Ixazomib Plus Lenalidomide Plus Dexamethasone for Newly Diagnosed Myeloma Patients

Phase 2

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Ixazomib
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2017-12-18

Last Posted Date: 2023-09-26

Lead Sponsor: Raija Silvennoinen

Target Recruit Count: 120

Registration Number: NCT03376672

Locations: 🇫🇮
Kuopio University Hospital, Kuopio, Finland
🇫🇮
Oulu University Hospital, Oulu, Finland
🇫🇮
Päijät-Häme Central Hospital, Lahti, Finland

and more 23 locations

Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery

Phase 3

Conditions: Sensorineural Hearing Loss
Cochlear Implant

Interventions: Drug: Sterile isotonic saline solution
Drug: Dexamethasone

First Posted Date: 2017-12-15

Last Posted Date: 2017-12-29

Lead Sponsor: Hospital Italiano de Buenos Aires

Target Recruit Count: 20

Registration Number: NCT03374514

Locations: 🇦🇷
HIBA, Caba, Buenos Aires, Argentina

A Safety, PK and Efficacy Study of CC-92480 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

Phase 1

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: CC-92480
Drug: Dexamethasone

First Posted Date: 2017-12-15

Last Posted Date: 2024-12-16

Lead Sponsor: Celgene

Target Recruit Count: 201

Registration Number: NCT03374085

Locations: 🇺🇸
Local Institution - 103, Duarte, California, United States
🇺🇸
Local Institution - 102, Atlanta, Georgia, United States
🇺🇸
Local Institution - 105, Boston, Massachusetts, United States

and more 51 locations

Intratympanic Stereoidal Injections for Facial Nerve Palsy

Not Applicable

Conditions: Bell Palsy

Interventions: Drug: Dexamethasone

First Posted Date: 2017-12-13

Last Posted Date: 2018-01-25

Lead Sponsor: Hillel Yaffe Medical Center

Target Recruit Count: 30

Registration Number: NCT03371589

The Effect of β-Carotene, Vitamin D3 and Zinc on Hyaline Membrane Disease and Feeding Intolerance in Premature Neonates

Phase 4

Conditions: Hyaline Membrane Disease
Necrotizing Enterocolitis of Newborn

Interventions: Dietary Supplement: Beta carotene
Drug: Dexamethasone
Dietary Supplement: Vitamin D3
Dietary Supplement: Zinc

First Posted Date: 2017-12-08

Last Posted Date: 2018-08-13

Lead Sponsor: Indonesia University

Target Recruit Count: 120

Registration Number: NCT03366584

Locations: 🇮🇩
Cipto Mangunkusumo General Hospital, Jakarta, DKI Jakarta, Indonesia

Dexamethasone in Controlling Dyspnea in Patients With Cancer

Phase 2

Active, not recruiting

Conditions: Dyspnea
Malignant Neoplasm

Interventions: Drug: Dexamethasone
Other: Questionnaire Administration
Other: Placebo

First Posted Date: 2017-12-08

Last Posted Date: 2024-10-23

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 135

Registration Number: NCT03367156

Locations: 🇺🇸
Lyndon B. Johnson Hospital, Houston, Texas, United States
🇺🇸
Harris Health System Settegast Health Center, Houston, Texas, United States
🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer

Phase 3

Completed

Conditions: Breast Carcinoma

Interventions: Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Netupitant/Palonosetron Hydrochloride
Drug: Olanzapine
Other: Placebo
Drug: Prochlorperazine
Other: Quality-of-Life Assessment

First Posted Date: 2017-12-08

Last Posted Date: 2024-12-24

Lead Sponsor: University of Rochester NCORP Research Base

Target Recruit Count: 1351

Registration Number: NCT03367572

Locations: 🇺🇸
Health Partners Inc, Minneapolis, Minnesota, United States
🇺🇸
Hawaii MU NCORP, Honolulu, Hawaii, United States
🇺🇸
Decatur Memorial Hospital, Decatur, Illinois, United States

and more 15 locations

Drug Development Updates

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